IRB Guidance and Resources

Cornell IRB guidance and policies, and links to external sources to help you plan, obtain, and maintain IRB approval for your project

Looking for guidance and resources? The links and documents below will help you to understand the main processes and guidelines used by the Cornell IRB, as well as external policies, regulations and best practices that might apply to your research using human participants.

Cornell IRB Guidance & Procedures

Start here: if you aren't sure whether your activity is covered under Cornell's Human Research Protection Program, review this Decision Tree.

Cornell IRB Procedures – submitting & managing IRB projects

Policy 1: Determining Whether a Research Activity Needs IRB Review and Approval

Policy 3: Expedited and Full Board Reviews (Initial, Amendment, and Continuing)

Guidance: Oral Histories, Journalism, and Case Studies

Guidance: Revised Common Rule: Cornell IRB Policies and Procedures

Policy 2: Requests for Exemption

Policy 17: Principal Investigator Roles and Responsibilities

Policy 8: Closing a Research Protocol

Policy 4: Reporting Unanticipated/Adverse Events

Policy 5: Managing Noncompliance

Policy 6: Suspensions and Terminations of IRB Protocols

Policy 7: Reporting Unanticipated Problems to Regulatory Agencies and Sponsors

Navigating External Rules and Requirements

Guidance: NIH Certificates of Confidentiality

Guidance: Clinical Trials

Guidance: Using HIPAA Data for Research

Policy 18: New York State Laws

Guidance: Revised Common Rule: Cornell IRB Policies and Procedures

Guidance: GDPR Research

Research with Special Populations

Guidance: Parent/Guardian Permission for Studies involving Children

Guidance: Managing Risk of Harm to Self or Others

Policy: International Human Research

Guidance: Preparing Protocols Involving International Research

Guidance: Research Involving Cognitively Impaired Adults

Informed Consent and Recruitment

Policy 9: Recruitment and Payment of Hu man Research Participants

Policy 10: Informed Consent Options, Processes, and Documentation

Policy 11: Informed Consent - Research Involving Children

Policy 12: Informed Consent - Research Involving Prisoners

Policy 13: Informed Consent - Research Involving Normal, Healthy Participants

Policy 15: Informed Consent - Research Involving Cornell Students

Guidance: Parent/Guardian Permission for Studies Involving Children

Guidance: Oral Consent

Informed Consent 101 Video

Research Involving Medical Procedures, Testing or Devices

Policy 19: Use of Physiological Devices, Biomedical Procedures or Biological Samples in Research

Guidance: Sanitation of Devices that Contact Intact Skin

Guidance: Managing Risk of Harm to Self or Others

Guidance: Venipuncture for Research on Human Subjects

Research Involving Technology & Data

Policy 16: Computer- and Internet-Based Survey Research

Policy 20: Use of Social Networking Sites and Mobile Devices

Guidance: Research Involving Existing or Secondary Data

External Regulations & Guidance

External Regulations & Guidance

Here is a list of selected laws, regulations and guidelines concerning the conduct of research with human participants:

The Federal Policy for the Protection of Human Subjects (the “Common Rule”)

The Belmont Report

HIPAA Privacy Rule

Family Educational Rights and Privacy Act (FERPA)

Food and Drug Administration (FDA) 21 CFR Regulations

General Data Protection Regulation (GDPR)

New York State’s Article 24-A: Protection of Human Subjects

New York Civil Rights Law Section 79-l: Confidentiality of records of genetic tests

13

Resource

About the IRB Committee

Resource

The Life Cycle of an IRB Protocol

Resource

IRB Announcements & Newsletters

Process

Research with Human Participants

Resource

IRB Informed Consent

Resource

IRB Training

Resource

IRB Considerations: Human Participant Data, Data Sets and Internet Research

Resource

IRB Biomedical Research

Resource

IRB Considerations for International Research

Resource

IRB Considerations for Clinical Trials

Resource

Multi-site and Collaborative IRB Research

See All

Scroll